MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.
An on-line search is available which allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated quarterly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.
MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.
Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.
The data is also available in zipped files for downloading. The data is updated on a quarterly basis.
These files were then compressed ("zipped") in order to save space. For these files to be useful to you, you'll first have to download them, unzip them, and then import them into a database or word processor for your further processing.
DISCLAIMER: Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. A file of those disclaimers will be placed on the web shortly.
The releasable MAUDE data is presented in four logical records types. For this data to be meaningful, you should download all four types of files. The four record formats contain all releasable information on MEDWATCH Form 3500A and 3500.
Downloading Hint: When downloading the MAUDE data files to a database such as Microsoft Access, it is recommended that you first open, then save the data file in Microsoft WORD. This will add an "end of record" marker to each MAUDE record that can be recognized by Microsoft ACCESS. For files such as the FOIDEV files, you may need to put in an extra character at the end of the first record prior to importing the file, otherwise the last column of data may be lost.
Master Event Data: A distinct master event data record will be present for each source reporting anevent. In other words, if a User Facility, Distributor, Manufacturer, and voluntary submitter all report an event, there will be four event records. These individual source records are related via the EVENT KEY. EVENT KEY is an internally-generated key which links multiple sources to a single event.
Device Data: Record Type 2 contains information related to the device(s) involved in the event.
Patient Data: Record Type 3 contains information related to the patient(s) involved in the event.
Text Data: Record Type 4 contains textual information from MEDWATCH Form Sections B5, H3, and H10.
All record types are linked via the MDR REPORT KEY.
For distributor reports which have had subsequent manufacturer reports, a special data element, MANUFACTURER LINK FLAG, will be set to 'Y'. In this case, the DISTRIBUTOR information (Section F on the master event data record) will be present; otherwise, these data elements will be blank.
The following files are available: (File Sizes are approximate)
File Name | Compressed Size in Bytes | Uncompressed Size in Bytes | Total Records | |
---|---|---|---|---|
MDRFOI.ZIP | 8011KB | 48185KB | 143458 | MAUDE Base records received to date for 2008 |
MDRFOIADD.ZIP | 687KB | 4615KB | 13698 | New MAUDE Base records for the current month. |
MDRFOICHANGE.ZIP | 744KB | 4366KB | 13031 | MAUDE Base data updates: changes to existing Base data. |
MDRFOITHRU2007.ZIP | 48744KB | 284257KB | 926399 | Master Record through 2007 |
PATIENT.ZIP | 1707KB | 7633KB | 143576 | MAUDE Patient Records received to date for 2008 |
PATIENTADD.ZIP | 135KB | 586KB | 13725 | New MAUDE Patient data for the current month. |
PATIENTCHANGE.ZIP | 129KB | 568KB | 13063 | Maude Patient data updates: changes to existing Patient data and additional Patient data for existing Base records. |
PATIENTTHRU2007.ZIP | 6914KB | 33690KB | 929895 | MAUDE Patient Records through 2007 |
DEVICEPROBLEMCODES.ZIP | 8KB | 21KB | 825 | Device Problem Codes |
FOIDEV2000.ZIP | 3643KB | 15229KB | 53299 | Device Data for 2000 |
FOIDEV2001.ZIP | 3903KB | 16360KB | 58074 | Device Data for 2001 |
FOIDEV2002.ZIP | 4156KB | 17361KB | 65812 | Device Data for 2002 |
FOIDEV2003.ZIP | 4255KB | 18053KB | 67847 | Device Data for 2003 |
FOIDEV2004.ZIP | 3594KB | 14973KB | 57057 | Device Data for 2004 |
FOIDEV2005.ZIP | 5658KB | 24826KB | 93510 | Device Data for 2005 |
FOIDEV2006.ZIP | 7975KB | 34806KB | 135075 | Device Data for 2006 |
FOIDEV2007.ZIP | 7649KB | 32642KB | 150657 | Device Data for 2007 |
FOIDEV98.ZIP | 4128KB | 17624KB | 63444 | Device Data for 1998 |
FOIDEV99.ZIP | 3540KB | 14867KB | 52882 | Device Data for 1999 |
FOIDEV.ZIP | 6596KB | 29179KB | 144303 | Device Data received to date for 2008 |
FOIDEVADD.ZIP | 637KB | 2648KB | 13766 | New MAUDE Device data for the current month. |
FOIDEVCHANGE.ZIP | 602KB | 2524KB | 13124 | Device data updates: changes to existing Device data and additional Device data for existing Base records. |
FOIDEVPROBLEM.ZIP | 1718KB | 6932KB | 538876 | Device Problem Codes |
FOIDEVTHRU97.ZIP | 7599KB | 31436KB | 136917 | Device Data through 1997 |
FOITEXT2000A.ZIP | 5337KB | 19497KB | 54514 | Narrative Data for January through June 2000 |
FOITEXT2000B.ZIP | 5303KB | 19263KB | 53058 | Narrative Data for July through December 2000 |
FOITEXT2001A.ZIP | 5467KB | 19445KB | 56835 | Narrative Data for January through June 2001 |
FOITEXT2001B.ZIP | 5707KB | 20520KB | 57696 | Narrative Data for July through December 2001 |
FOITEXT2002A.ZIP | 6116KB | 22004KB | 60293 | Narrative Data for January through June 2002 |
FOITEXT2002B.ZIP | 5946KB | 21834KB | 60224 | Narrative Data for July through December 2002 |
FOITEXT2003A.ZIP | 5633KB | 21204KB | 59474 | Narrative Data for January through June 2003 |
FOITEXT2003B.ZIP | 6098KB | 21966KB | 59371 | Narrative Data for July through December 2003 |
FOITEXT2004A.ZIP | 5381KB | 19118KB | 46477 | Narrative Data for January through June 2004 |
FOITEXT2004B.ZIP | 6099KB | 21734KB | 50194 | Narrative Data for July through December 2004 |
FOITEXT2005A.ZIP | 10265KB | 36763KB | 101424 | Narrative Data for January through June 2005 |
FOITEXT2005B.ZIP | 7914KB | 28469KB | 75657 | Narrative Data for July through December 2005 |
FOITEXT2006A.ZIP | 12771KB | 46152KB | 125297 | Narrative Data for January through June 2006 |
FOITEXT2006B.ZIP | 11613KB | 45239KB | 109971 | Narrative Data for July through December 2006 |
FOITEXT2007A.ZIP | 11058KB | 41463KB | 105303 | Narrative Data for January through June 2007 |
FOITEXT2007B.ZIP | 13680KB | 50225KB | 132860 | Narrative Data for July through December 2007 |
FOITEXT.ZIP | 24223KB | 87461KB | 232373 | Narrative Data received to date for 2008 |
FOITEXT96.ZIP | 3981KB | 13864KB | 45320 | Narrative Data for 1996 |
FOITEXT97A.ZIP | 6051KB | 21961KB | 73047 | Narrative Data for January through June 1997 |
FOITEXT97B.ZIP | 5776KB | 21296KB | 67661 | Narrative Data for July through December 1997 |
FOITEXT98A.ZIP | 5553KB | 20908KB | 60290 | Narrative Data for January through June 1998 |
FOITEXT98B.ZIP | 4226KB | 15069KB | 44999 | Narrative Data for July through December 1998 |
FOITEXT99A.ZIP | 4000KB | 14033KB | 38584 | Narrative Data for January through June 1999 |
FOITEXT99B.ZIP | 4622KB | 16789KB | 46395 | Narrative Data for July through December 1999 |
FOITEXTADD.ZIP | 2218KB | 9848KB | 25490 | New MAUDE Narrative data for the current month. |
FOITEXTCHANGE.ZIP | 2399KB | 9492KB | 24061 | Narrative data updates: changes to existing Narrative data and additional Narrative data for existing Base records. |
FOITEXTTHRU95.ZIP | 3638KB | 16869KB | 27404 | Narrative data through 1995 |
Note: This documentation is intended to be used in conjunction with a copy of Medwatch Form 3500A and 3500.
Record/Data Characteristics:
Special Note for REPORT NUMBER data element:
The REPORT NUMBER data element represents Manufacturer Report Number, Distributor Report Number, or internally-generated voluntary report number, depending on the source of the record.
This REPORT NUMBER field will be blank when:
Special Notes for Voluntary Reports and User Facility Malfunction Reports:
The only data elements which will be present on the Master Event Record will be:
All other data elements will be blank.
MDRFOI file contains following 75 fields, delimited by pipe (|), one record per line:
1. MDR Report Key
2. Event Key
3. Report Number
4. Report Source Code
P = Voluntary report
U = User Facility report
D = Distributor report
M = Manufacturer report
5. Manufacturer Link Flag (internal information flag)
6. Number Devices in Event (if source code is 'P', field will be null)
7. Number Patient in Event (if source code is 'P', field will be null)
8. Date Received
SECTION-B
9. Adverse Event Flag (B1)
10. Product Problem Flag (B1)
11. Date Report (B4)
12 Date of Event (B3) -- new added, 2006
13 Single Use Flag (Reprocessor Flag) (D8) -- new added, 2006
14 Reporter Occupation Code (E3) -- new added, 2006
SECTION-E (if source code is 'P', Section E to H will contain no data)
15. Health Professional (E2)
16. Initial Report to FDA (E4)
Y = Yes
N = No
U = Unknown
* = No answer provided
SECTION-F
17. Distributor Name (F3) -- if report source code = 'M' and
Manufacturer link flag is 'Y', fields 14 - 20 will contain data;
otherwise they will be null
18. Distributor Address (F3)
19. Distributor Address (F3)
20. Distributor City (F3)
21. Distributor State Code (F3)
22. Distributor Zip Code (F3)
23. Distributor Zip Code Ext (F3)
24. Date Facility Aware (F6)
25. Type of Report (F7) !multiple submission type, separate by ','
I = Initial submission
F = Followup
X = Extra copy received
O = Other information submitted
26. Report Date (F8)
27. Report to FDA (F11)
28. Date Report to FDA (F11)
29. Event Location (F12)
30. Report to Manufacturer (F13)
31. Date Report to Manufacturer (F13)
32. Manufacturer Name (F14)
33. Manufacturer Address (F14)
34. Manufacturer Address (F14)
35. Manufacturer City (F14)
36. Manufacturer State Code (F14)
37. Manufacturer Zip Code (F14)
38. Manufacturer Zip Code Ext (F14)
39. Manufacturer Country Code (F14)
40. Manufacturer Postal Code (F14)
SECTION-G (only for report source 'M', others sources will be null)
41. Manufacturer Contact Title Name (G1)
42. Manufacturer Contact First Name (G1)
43. Manufacturer Contact Last Name (G1)
44. Manufacturer Contact Street 1 (G1)
45. Manufacturer Contact Street 2 (G1)
46. Manufacturer Contact City (G1)
47. Manufacturer Contact State Code (G1)
48. Manufacturer Contact Zip Code (G1)
49. Manufacturer Contact Zip Code Ext (G1)
50. Manufacturer Contact Country Code
51. Manufacturer Contact Postal Code
52. Manufacturer Contact Phone No Area Code (G1)
53. Manufacturer Contact Phone No Exchange (G2)
54. Manufacturer Contact Phone No (G2)
55. Manufacturer Contact Phone No Ext (G2)
56. Manufacturer Contact Phone No Country Code
57. Manufacturer Contact Phone No City Code
58. Manufacturer Contact Phone No Local
59. Manufacturer G1 Name (G1)
60. Manufacturer G1 Street 1 (G1)
61. Manufacturer G1 Street 2 (G1)
62. Manufacturer G1 City (G1)
63. Manufacturer G1 State Code (G1)
64. Manufacturer G1 Zip Code (G1)
65. Manufacturer G1 Zip Code Ext (G1)
66. Manufacturer G1 Country Code
67. Manufacturer G1 Postal Code
68. Source Type (G3) -- multiple source type, separate by ','
00 Other
01 Foreign
02 Study
03 Literature
04 Consumer
05 Health Professional
06 User facility
07 Company representation
08 Distributor
99 Unknown
* Invalid data
69. Date Manufacturer Received (G4)
SECTION-H
70. Device Date Of Manufacture (H4)
71. Single Use Flag (H5)
72. Remedial Action (H7) -- multiple source type, separate by ','
RC = Recall
RP = Repair
RL = Replace
RB = Relabeling
OT = Other
NO = Notification
IN = Inspection
PM = Patient Monitoring
MA = Modification/Adjustment
* = Invalid Data
73. Previous Use Code (H8)
74. Removal/Correction Number (H9)
75. Event type (H1) -- only relevant for report sourcetype 'M'
D = Death
IN = Injury
IL = Injury
IJ = Injury
M = Malfunction
O = Other
* = No answer provided
DEVICE file contains following 45 fields, delimited by pipe (|), one record per line:
1. MDR Report Key
2. Device Event key
3. Implant Flag -- D6, new added; 2006
4. Date Removed Flag -- D7, new added; 2006; if flag in M or Y, print Date
5. Device Sequence No -- from device report table
6. Date Received (from mdr_document table)
SECTION-D
7. Brand Name (D1)
8. Generic Name (D2)
9. Manufacturer Name (D3)
10. Manufacturer Address 1 (D3)
11. Manufacturer Address 2 (D3)
12. Manufacturer City (D3)
13. Manufacturer State Code (D3)
14. Manufacturer Zip Code (D3)
15. Manufacturer Zip Code ext (D3)
16. Manufacturer Country Code (D3)
17. Manufacturer Postal Code (D3)
18. Device Operator (D4)
19. Expiration Date of Device (D5)
20. Model Number (D6)
21. Catalog Number (D6)
22. Lot Number (D6)
23. Other ID Number (D6)
24. Device Availability (D9)
Y = Yes
N = No
R = Device was returned to manufacturer
* = No answer provided
25. Date Returned to Manufacturer (D9)
26. Device Report Product Code
27. Device Age (F9)
28. Device Evaluated by Manufacturer (H3)
Y = Yes
N = No
R = Device not returned to manufacturer
* = No answer provided
BASELINE SECTION
29. Baseline brand name
30. Baseline generic name
31. Baseline model no
32. Baseline catalog no
33. Baseline other id no
34. Baseline device family
35. Baseline shelf life contained in label
Y = Yes
N = No
A = Not applicable
* = No answer provided
36. Baseline shelf life in months
37. Baseline PMA flag
38. Baseline PMA no
39. Baseline 510(k) flag
40. Baseline 510(k) no
41. Baseline preamendment
42. Baseline transitional
43. Baseline 510(k exempt flag
44. Baseline date) first marketed
45. Baseline date ceased marketing
PATIENT file contains following 5 fields, delimited by pipe (|), one record per line:
1. MDR Report Key (from patient report table)
2. Patient Sequence Number (from patient report table)
3. Date Received (from mdr_document table)
4. Sequence Number||','|| Treatment -- multiple source type, separate by ';'
5. Sequence Number||','|| Outcome -- multiple source type, separate by ';'
L - Life Threatening
H - Hospitalization
S - Disability
C - Congenital Anomaly
R - Required Intervention
O - Other
* - Invalid Data
U - Unknown
I - No Information
A - Not Applicable
D - Death
TEXT file contains following 6 fields, delimited by pipe (|), one record per line:
1. MDR Report Key
2. MDR Text Key
3. Text Type Code (D=B5, E=H3, N=H10 from mdr_text table)
4. Patient Sequence Number (from mdr_text table)
5. Date Report (from mdr_text table)
6. Text (B5, or H3 or H10 from mdr_text table)
FOIDEVPROBLEM contains following 3 fields, delimited by pipe (|), one record
per line:
1. MDR Report Key
2. Device Problem Code -- (F10) new added; 2006
DEVICEPROBLEMCODES contains following 2 fields, delimited by pipe (|),
one record per line:
1. Device Problem Code
2. Problem Description
* INVALID DATA
000 OTHER 001 HOSPITAL 002 HOME 003 NURSING HOME 004 OUTPATIENT TREATMENT FACILITY 005 OUTPATIENT DIAGNOSTIC FACILITY 006 AMBULATORY SURGICAL FACILITY 500 HOSPITAL 501 CATHETERIZATION SUITE 502 CRITICAL CARE UNIT 503 DIALYSIS UNIT 504 EMERGENCY ROOM 505 EXAMINATION ROOM 506 LABORATORY/PATHOLOGY DEPARTMENT 507 MATERNITY WARD - NURSERY 508 OPERATING ROOM 509 OUTPATIENT CLINIC/SURGERY 510 PATIENT'S ROOM OR WARD 511 RADIOLOGY DEPARTMENT 600 AMBULATORY HEALTH CARE FACILITY 601 AMBULATORY SURGICAL CENTER 602 BLOOD BANK 603 BLOODMOBILE 604 CATHETERIZATION LAB - FREE STANDING 605 CHEMOTHERAPY CENTER 606 CLINIC - WALK IN, OTHER 607 DIALYSIS CENTER 608 DRUG CLINIC |
609 IMAGING CENTER - MOBILE
610 IMAGING CENTER - STATIONARY 611 LABORATORY 612 MOBILE HEALTH UNIT 613 MRI CENTERS 614 PSYCHIATRIC CENTER - WALK IN, OTHER 615 TUBERCULOSIS CLINIC 616 URGENT CARE CENTER 617 OUTPATIENT DIAGNOSTIC FACILITY 700 LONG-TERM CARE FACILITY 701 HOSPICE 702 NURSING HOME 703 PSYCHIATRIC FACILITY 704 REHABILITATION CENTER 705 RETIREMENT HOME 810 PATIENT'S HOME 820 IN TRANSIT TO USER/MEDICAL FACILITY 830 PUBLIC VENUE 831 OUTDOORS 832 PARK 833 PLAYGROUND 834 PUBLIC BUILDING 835 SCHOOL 836 STREET 999 UNKNOWN NA NOT APPLICABLE NI NO INFORMATION UNK UNKNOWN |
Updated November 6, 2008
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